Human Amniotic Membrane On Venous Leg Ulcers In an Elderly Population

Launched by BIOLAB HOLDINGS · Aug 5, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at the use of human amniotic membranes to help heal venous leg ulcers, which are wounds on the legs that are slow to heal due to poor blood flow. The study will involve older adults, specifically those between 50 and 85 years old, who have had these ulcers for at least a month and have not seen improvement with standard treatments. To participate, individuals need to have ulcers that are a certain size and meet specific medical criteria.

Participants in this trial can expect to receive treatment with the amniotic membrane over a 12-week period, and they will be monitored closely to see how well their ulcers heal. It's important to note that individuals with certain health conditions, such as severe infections or those receiving certain medications, will not be eligible to take part. The study is not yet recruiting participants, but it aims to find new ways to help heal these challenging wounds in the elderly population.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• In order to be eligible to participate in this study, subjects must meet all of the following criteria:
• • 1. Ulcers of venous origin, as determined by clinical signs and symptoms (e.g. hyperpigmentation of the surrounding skin, history of swelling, varicosities, lipodermatosclerosis and/or dermatitis) or other assessments (e.g. venous reflux test). If the subject has multiple on the same leg and/or bilateral ulcers, the largest should be selected.
• • 2. Venous insufficiency ulcers, of at least 1-month duration, which have not adequately responded to conventional ulcer therapy
• • 3. Venous insufficiency ulcers between 2 cm2 and 16 cm2
• • 4. Venous ulcer has not reduced in area ≥40% from baseline measurements during the 2-week screening period
• • 5. Partial- or full-thickness VLU, including ulcers with tissue damage that extends through the epidermis and into the upper epidermis (papillary dermis), or into the deep dermis
• • 6. Subjects are between 50 and 85 years of age.
• • 7. Subject is expected to be available for 12-week follow-up
• • 8. Subject, or their Legally Authorized Representative (LAR), has read, understood, and signed the IRB/IEC approved Informed Consent Form before screening procedures are undertaken.
• Subjects who meet any of the following criteria will be excluded from participating in this study:
• • 1. Ankle Brachial Index (ABI) of \<0.7 or Toe Brachial Index (TBI) \<0.5
• • 2. Vasculitis, severe rheumatoid arthritis, and other collagen vascular diseases
• • 3. Clinically significant medical conditions which would impair wound healing, as determined by the investigator, including renal, hepatic, hematologic, neurologic or immune disease
• • 4. Signs and symptoms of infection, cellulitis, osteomyelitis
• • 5. Necrotic ulcer beds
• • 6. Subjects receiving hemodialysis or have uncontrolled diabetes: defined as A1C of greater than or equal to 12. An existing A1C value is allowed if completed within 3 months of subject screening.
• • 7. Subjects who are currently receiving or have received at any time within one month prior to entry into the study, corticosteroids (\>15 mg/day), immunosuppressive agents, radiation therapy, or chemotherapy. Anticipated use of the above agents will exclude subjects from entry into the study.
• • 8. Wound unable to be debrided or subject not able to tolerate debridement
• • 9. Subject not willing or able to comply with compression requirements
• • 10. Subjects enrolled in other wound investigational studies within the past three months, or device studies within the past 30 days.